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| Name | Class |
|---|---|
| Twine Clinical Consulting | UNKNOWN |
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The goal of the Twine / University of Michigan Diabetes Quality Improvement Initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (CGM) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (T2D).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Comparator- High Risk | Active Comparator | A high risk sub group of those assigned to the comparator arm will be identified by their most recent A1C > 8. Patients in this group will receive usual care from their Primary Care Physician and dietitian. |
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| Comparator- Well Controlled | Active Comparator | The low risk sub group from the comparator arm (A1C < 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their Primary Care Physician and their dietitian. |
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| Enhanced Care- High Risk | Experimental | A high risk sub group of those assigned to the enhanced care arm will be identified by their most recent A1C > 8. Patients in this group will receive the intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring. |
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| Enhanced Care- Well Controlled. | Experimental | The low risk sub group from the enhanced care arm (A1C < 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their PCP and their dietitian. If they are found to be poorly controlled through monthly screening for risk, they may have the opportunity to move into the Enhanced Care High Risk group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual Care | Other | Usual care from Primary Care Physician and dietitian. |
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| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | Hemoglobin A1C | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Weight Change | Difference in patient's weight measured in pounds. | baseline to 1 year |
| Change in diabetes medication requirements | Change in average daily doses of diabetes medications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Richardson, M.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chelsea Health Center | Chelsea | Michigan | 48118 | United States |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D012306 | Risk |
| ID | Term |
|---|---|
| D011336 | Probability |
| D013223 | Statistics as Topic |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
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| Intensive Behavioral Intervention | Behavioral | The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring. |
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| Monthly Screening for Risk | Other | Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval. |
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| baseline to 1 year |
| Change in percentage of time glucose is out of range | Change in percentage of time glucose is out of range (70 mg/dl-140 mg/dl) on CGM. | baseline to 1 year |
| Blood Pressure | Blood Pressure | 1 year |
| Change in rate of Micro-vascular complications | Change in rate of micro-vascular complications. (The micro-vascular complications assessed will be retinopathy, neuropathy, nephropathy) | Baseline to 1 Year |
| Change in rate of symptomatic hypoglycemia requiring medical intervention | Change in rate of symptomatic hypoglycemia requiring medical intervention | Baseline to 1 year |
| D004700 | Endocrine System Diseases |
| D055641 |
| Mathematical Concepts |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |